Events

Recall of Scorpio

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33035
  • Event Risk Class
    Class 2
  • Event Number
    Z-0058-06
  • Event Initiated Date
    2005-08-11
  • Event Date Posted
    2005-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41230
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
  • Reason
    The left scorpio total knee cruciate retaining waffle femoral component #7 packaged and labeled as left may contain a right and vice versa.
  • Action
    The recall notification was sent out via FedEx on 8/11/2005 with requested return receipt.

Device

Scorpio
  • Model / Serial
    Catalog No: 70-4107L Lot Code: K04W537
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was distributed to their sales representatives/sales agencies, hospitals, and international distribution. The product was shipped to Stryker Germany and Stryker France.
  • Product Description
    Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA